Serious riskFDA DrugApr 15, 2026Class II

Fresenius Kabi sodium chloride injection recalled for sterility assurance issue

Fresenius Kabi USA is recalling specific batches of 0.9% Sodium Chloride Injection (a sterile saline solution) because the manufacturer cannot guarantee the product is free from contamination. The affected batches were distributed nationwide, including Alaska and Puerto Rico, between now and June 2027.

From the FDA notice · Read the official notice ↗ · All Fresenius Kabi recalls

What to do

Check if you have any of the affected batch numbers (6402153, 6402297, 6402298, 6402377, 6402378, 6402379, 6402429, 6402430, 6402431, 6402432, 6402433, 6402434, 6402512, 6402574, or 6402576)
Do not use the product if you have an affected batch
Contact your pharmacy, hospital, or healthcare provider if you have received this product
Speak with your doctor or pharmacist about a safe replacement

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.
Sold in: Nationwide
Made for: All ages

This recall covers 14 products — see all of them.

Details

Illnesses reported: None reported
Manufactured in: 3 Corporate Dr, Lake Zurich, IL, United States
Classification: Class II
Recall number: D-0430-2026

In the FDA's words

Description: 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03. Lack of Assurance of Sterility Batch# 6402153, Exp Date: 11/30/2026; Batch# 6402297, 6402298, Exp Date: 01/31/2027; Batch# 6402377, 6402378, 6402379, Exp Date: 02/28/2027; Batch # 6402429, 6402430, 6402431, 6402432, 6402433, Exp Date: 03/31/2027; Batch# 6402434, Exp Date: 04/30/2027; Batch# 6402512, Exp Date: 05/2027; Batch# 6402574, 6402576, Exp Date: 06/30/2027. Distribution: US Nationwide , Alaska, and Puerto Rico.
Hazard: Lack of Assurance of Sterility

14 products in this recall

Fresenius Kabi IV saline and dextrose bags recalled over sterility

Fresenius Kabi is recalling 14 sodium chloride and dextrose IV fluid bags because the company cannot assure they are sterile. The products were sold under the Fresenius Kabi, BD and Fresenius Medical Care names and were distributed nationwide, to Alaska and to Puerto Rico. No injuries have been reported.

The agency lists each product separately. Check every one you might have.